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FDA now demands its strongest black box warnings for certain opioid and other drugs

On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines.

FDA prepared a Drug Safety Communication directed to health care professionals and patients, generally advising of the risks of combined use of certain opioid medicines and benzodiazepines, and also issued a Response Letter to a February 24, 2016 citizen petition (Docket No. FDA-2016-P-0689). FDA’s Response Letter provides notice of FDA’s action to require boxed safety warnings and new or revised Medication Guides for three drug classifications – i.e., opioid analgesics, prescription opioid cough products, and benzodiazepines.

Highlights from both FDA’s Response Letter and Drug Safety Communication are set forth below.

FDA Response Letter

In direct response to a February 24, 2016 citizen petition, FDA issued a Response Letter on August 31, 2016, requiring new safety information and labeling changes for certain drug classifications. FDA explains in its Response Letter that sufficient evidence exists warning of the serious risks of sedation, respiratory depression, coma, and death associated with combined use of benzodiazepines or central nervous system (“CNS”) depressants (including alcohol) and opioid medicines. As a result, FDA has concluded that a boxed warning is appropriate to highlight these serious risks.

The Response Letter outlines the following key safety warning and labeling changes:

All three drug classifications (opioid analgesics, prescription opioid cough products, and benzodiazepines) require a boxed safety warning, although the language will vary slightly.

General Warning. The boxed safety warning for all three drug classifications must include a general warning, stating that combined use of opioid analgesics and benzodiazepines or other CNS depressants, including alcohol, “may result in profound sedation, respiratory depression, coma, and death.”

The boxed safety warning for opioid analgesics and benzodiazepines must state, in addition to the general warning, that:

For opioid analgesics, prescribers should “reserve concomitant prescribing of TRADENAME and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.”

For benzodiazepines, prescribers should “reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.”

Prescribers should “limit dosages and duration to the minimum required.”

Prescribers should “follow patients for signs and symptoms of respiratory depression and sedation

The boxed safety warning for patients taking prescription opioid cough products must state, in addition to the general warning, that prescribers should “avoid use of opioid cough medications in patients taking benzodiazepines.”

FDA’s Drug Safety Communication provides a general overview of the risks associated with combined use of opioid medicines with benzodiazepines and other CNS depressants and generally echoes the language captured by the new boxed safety warning and labeling changes.

The Drug Safety Communication also advises health care professionals and patients that new or revised patient Medication Guides are forthcoming and will include the new boxed warnings and revisions to the “Warnings and Precautions, Drug Interactions” and “Patient Counseling Information” sections of drug labels.

FDA’s new boxed safety warning and labeling changes are part of FDA’s Opioids Action Plan, which aims to reverse the opioid abuse epidemic and better inform health care professionals, prescribers, and patients of the risks associated with certain opioid drugs.